Albuterol Sulfate

Product NDC: 76204-200
11-digit product format: 762040200
Labeler code: 76204
Product ID: 76204-200_4ffe0388-e743-7259-e063-6394a90a94d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Ritedose Pharmaceuticals, LLC
Application: ANDA077839
Marketing category: ANDA
Marketing start: 2011-12-05
Substance: ALBUTEROL SULFATE
Active strength: 2.5 mg/3mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077839-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN		2008-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077839-001	AN

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077839-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077839-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077839-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077839-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077839-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077839-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077839-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077839-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077839-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077839-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077839-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077839-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077839-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077839-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077839-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077839-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077839-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077839-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077839-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077839-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077839-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077839-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077839-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077839-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077839-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077839-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077839-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077839-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077839-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077839-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077839-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077839-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077839-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077839-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077839-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077839-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077839-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077839-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077839-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077839-001	AN	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Albuterol Sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALBUTEROL SULFATE	2.5 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
021SEF3731	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
630208	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b72742df-1a6b-4483-aff3-3e79db5e015d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
26005090-31a1-441d-920b-db3101a55d53	Product name	3	20250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04b	Product name	3	20250218
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76204-200-01	Albuterol Sulfate	30 in 1 CARTON	SOLUTION	30	20
76204-200-01	Albuterol Sulfate	1 in 1 POUCH	SOLUTION	1	20
76204-200-25	Albuterol Sulfate	25 in 1 POUCH	SOLUTION	25	20
76204-200-25	Albuterol Sulfate	1 in 1 CARTON	SOLUTION	1	20
76204-200-30	Albuterol Sulfate	1 in 1 CARTON	SOLUTION	1	20
76204-200-30	Albuterol Sulfate	30 in 1 POUCH	SOLUTION	30	20
76204-200-60	Albuterol Sulfate	30 in 1 POUCH	SOLUTION	30	20
76204-200-60	Albuterol Sulfate	2 in 1 CARTON	SOLUTION	2	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76204-200-01	ML - Milliliter	76204-200	14f3189a-aabf-4273-81ff-3117fb53448e	1	2013-11-04
76204-200-25	ML - Milliliter	76204-200	222a6282-c73d-4d52-a540-16238cc6bac6	1	2012-07-24
76204-200-30	ML - Milliliter	76204-200	0f1fa0ae-de95-4fd6-ade0-d8a844d28770	1	2012-07-24
76204-200-60	ML - Milliliter	76204-200	ca17bc17-793c-4595-af9a-71d667f2b84d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Albuterol Sulfate	ACTIVE INGREDIENT	021SEF3731	ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	4
Albuterol	ACTIVE MOIETY	QF8SVZ843E	ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	4
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	4
Sulfuric Acid	INACTIVE INGREDIENT	O40UQP6WCF	ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	4
Water	INACTIVE INGREDIENT	059QF0KO0R	ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	4
ALBUTEROL SULFATE	ACTIVE INGREDIENT	021SEF3731	ALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
ALBUTEROL	ACTIVE MOIETY	QF8SVZ843E	ALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	ALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76204-200	ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	17	Current NDC, Legacy NDC, 8 package rows	20241219_b72742df-1a6b-4483-aff3-3e79db5e015d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	4aec7f59-b429-4b0e-a779-8df1dd8f80d7	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	b72742df-1a6b-4483-aff3-3e79db5e015d	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839 ndc (product): 76204-200
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	6ec88f64-66a2-4ca9-9913-c192fc33f88b	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	c90e80b2-882e-4c0c-bfac-d67eb1da724d	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Mylan Pharmaceuticals Inc.	5329614f-ae0b-4854-bb6f-ea0b7dae87c0	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals, Inc.	2c3f975c-dbd8-0362-e063-6394a90a16dd	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	19867b61-77a2-46f1-97c7-7fadfec5882b	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Medical Purchasing Solutions, LLC	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
021SEF3731	ALBUTEROL SULFATE	51022-70-9	ALBUTEROL SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	19867b61-77a2-46f1-97c7-7fadfec5882b	22
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	19867b61-77a2-46f1-97c7-7fadfec5882b	22
630208	albuterol 0.083 % Inhalation Solution	SY	19867b61-77a2-46f1-97c7-7fadfec5882b	22
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	19867b61-77a2-46f1-97c7-7fadfec5882b	22
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	19867b61-77a2-46f1-97c7-7fadfec5882b	22
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	b72742df-1a6b-4483-aff3-3e79db5e015d	20
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	b72742df-1a6b-4483-aff3-3e79db5e015d	20
630208	albuterol 0.083 % Inhalation Solution	SY	b72742df-1a6b-4483-aff3-3e79db5e015d	20
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	b72742df-1a6b-4483-aff3-3e79db5e015d	20
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	b72742df-1a6b-4483-aff3-3e79db5e015d	20
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	6
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	6
630208	albuterol 0.083 % Inhalation Solution	SY	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	6
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	6
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	6
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	3
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	3
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol 0.083 % Inhalation Solution	SY	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	3
630208	albuterol 0.083 % Inhalation Solution	SY	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	3
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	3
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	2c3f975c-dbd8-0362-e063-6394a90a16dd	3
630208	albuterol sulfate 0.083 % Inhalation Solution	PSN	05f7916c-52f7-4a4f-a19b-f5e35f02fd0b	1
630208	albuterol 0.83 MG/ML Inhalation Solution	SCD	05f7916c-52f7-4a4f-a19b-f5e35f02fd0b	1
630208	albuterol 0.083 % Inhalation Solution	SY	05f7916c-52f7-4a4f-a19b-f5e35f02fd0b	1
630208	albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation Solution	SY	05f7916c-52f7-4a4f-a19b-f5e35f02fd0b	1
630208	albuterol 2.5 MG per 3 ML Inhalation Solution	SY	05f7916c-52f7-4a4f-a19b-f5e35f02fd0b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76204-200-01	76204020001	30 POUCH in 1 CARTON (76204-200-01) / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE	30 pouch	2011-12-05	0000-00-00	No	No	Current
76204-200-25	76204020025	1 POUCH in 1 CARTON (76204-200-25) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE	1 pouch	2011-12-05	0000-00-00	No	No	Current
76204-200-30	76204020030	1 POUCH in 1 CARTON (76204-200-30) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE	1 pouch	2011-12-05	0000-00-00	No	No	Current
76204-200-60	76204020060	2 POUCH in 1 CARTON (76204-200-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE	2 pouch	2011-12-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Inhalation Solution, USP 0.083% 2.5 mg/3 mL	Ritedose Pharmaceuticals, LLC	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	20
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL	Cardinal Health 107, LLC	2026-04-20	HUMAN PRESCRIPTION DRUG LABEL	6
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)	NuCare Pharmaceuticals, Inc.	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	3
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)	REMEDYREPACK INC.	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	4
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)	A-S Medication Solutions	2024-05-07	HUMAN PRESCRIPTION DRUG LABEL	22
Albuterol Sulfate - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-05-30	HUMAN PRESCRIPTION DRUG LABEL	3
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
ALBUTEROL SULFATE FOR PROVENTIL	Aidarex Pharmaceuticals LLC	2013-11-14	HUMAN PRESCRIPTION DRUG LABEL	1